Confusion prevails among the state drug authorities and the industry over the status of the union health ministry's notification dated 10/2/2011 in which it had banned six drugs including nimesulide for below 12 years of age and combination of PPA (phenylpropanolamine HCL).

Even though the Madras High Court had stayed the notification subsequently, there are complaints that the state drug authorities are not issuing manufacturing licenses on the grounds that the Drug Controller General of India (DCGI) has not yet issued any specific guidelines on receipt of Madras High Court orders. “Upon receipt of the notification, the state drug authorities had asked the manufacturers to surrender the licenses for cancellation. But, even after the Madras High Court's stay on the notification, the concerned FDAs are not issuing the licenses and are as a matter of dilly- dallying tactics referring the requests of manufacturers to technical officers,” sources said.

Immediately after the notification, the authorities were prohibiting the distribution and sale of these formulations. But, after the court stay, these same authorities have stopped taking action on sale/distribution of these formulations and the sale is freely allowed thereafter. Under this situation not issuing licenses for manufacturers by these same authorities is not understandable, sources said.

“In ethical promotion, we are getting very good response for the product nimesulide suspension as there is a segment of paediatricians, who are strong supporters of nimesulide as NSAID in management of pain and fever in paediatric patients.  As per these doctors, there is no bad experience or any negative report on this molecule. The role of FDAs in non-issuing of the license for this product in spite of unambiguous orders of Madras High Court is not tenable and posing constraint in business,” a manufacturer said.

He further said that same is the story of phenylpropanolamine. The general physicians are prescribing these time tested combinations in management of cold and fever. There is good and continuous demand in market for combinations of PPA. It is however, observed that the PPA as API is not available in the market. Though the PPA is manufactured by them, they are not permitted by concerned FDAs to sale PPA to local manufacturers. The sale of PPA is only permitted to export market/export manufacturers.

Immediately after the controversial notification last year, the CIPI had moved the Madras High Court, praying to allow time for the companies to liquidate their stocks. In its order on March 15, 2011, the court allowed the drug companies to liquidate the stocks of nimesulide suspension and PPA. Later on March 23, the court merged the CIPI case with another similar case filed by pharma major Cipla Ltd. Hearing the petition filed by Cipla, the court had stayed the entire notification of the ministry (GSR 82 E) dated February 10, 2011.

But, confusion prevailed in the market over the status of the notification once CIPI decided to withdraw the case citing several reasons, including short of funds to continue the case in the court. After the exit of CIPI from the case, there were contradicting interpretations about the status of the case, even among the regulatory authorities. There was a plea that since the court has allowed the stay to Cipla, it is applicable to it only.

But, legal experts like Manoj Tongra have clarified that since the court had stayed the entire notification, it is status quo ante, meaning companies can sell all these products as before the notification.

Though the hearing on this high voltage case has been concluded way back  in September last year and the court had reserved its judgment, it is yet to deliver the final order. But, it did not vacate the stay either.